Clinical Trials Logo

Clinical Trial Summary

This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other half will be given placebo. An additional group of HIV positive patients without Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and diarrhea.


Clinical Trial Description

Cryptosporidiosium infection and diarrhea is a life-threatening infection in children 6-18 months and in immunocompromised patients. However, Nitazoxanide, the only drug approved for treatment of Cryptosporidiosis, showed little-to-no efficacy in HIV positive patients and low efficacy in malnourished children.

Recently, Love MS et al reported that Clofazimine inhibited proliferation of both Cryptosporidium parvum and C. hominis in vitro and reduced shedding in a mouse model of acute C. parvum infection. Clofazimine has been approved for treatment of leprosy for decades and more recently for the treatment of drug-resistant Mycobacterium tuberculosis. Safety and pharmacokinetics of Clofazimine are well documented for a variety of patient populations, but not for HIV positive patients or patients with diarrhea. Thus, this clinical trial seeks to determine the efficacy of 50 or 100 mg of Clofazimine administered 3 times daily for 5 days on fecal shedding of Cryptosporidium oocysts in HIV positive patients, as well as safety, tolerability, and pharmacokinetics in this patient population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03341767
Study type Interventional
Source University of Washington
Contact
Status Terminated
Phase Phase 2
Start date December 14, 2017
Completion date July 5, 2019

See also
  Status Clinical Trial Phase
Terminated NCT00057486 - Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients Phase 1/Phase 2
Completed NCT00507871 - Transmission and the Respiratory Tract in Cryptosporidiosis N/A
Terminated NCT00001162 - Parasitic Infections of the Gastrointestinal Tract N/A
Recruiting NCT05208970 - Cryptosporidium Species in Sohag Governorate
Recruiting NCT04332705 - Cryptosporidium Infection and Human Colorectal Cancer
Active, not recruiting NCT02764918 - Cryptosporidiosis and Enteropathogens in Bangladesh
Not yet recruiting NCT01695304 - Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya N/A
Terminated NCT00004986 - Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients Phase 3
Completed NCT04103216 - Treatment of Cryptosporidiosis N/A
Completed NCT01699841 - Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events N/A
Active, not recruiting NCT00002158 - A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis N/A
Completed NCT00055107 - Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children Phase 1/Phase 2
Completed NCT00000771 - A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Phase 2
Terminated NCT00001128 - Treatment of Chronic Cryptosporidiosis in AIDS Patients N/A
Completed NCT00002248 - A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients Phase 1
Completed NCT00002264 - The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea N/A
Completed NCT00002027 - Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) N/A
Completed NCT00002082 - Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study N/A
Completed NCT00002328 - Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs N/A
Completed NCT00001081 - A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium Phase 2